{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"87.9","upperLimit":"208.0","value":"156"},{"groupId":"OG001","lowerLimit":"170.5","upperLimit":"335.0","value":"218.5"},{"groupId":"OG002","lowerLimit":"174.0","upperLimit":"365.5","value":"303.5"},{"groupId":"OG003","lowerLimit":"238.0","upperLimit":"689.0","value":"419"},{"groupId":"OG004","lowerLimit":"214.0","upperLimit":"2367.0","value":"363.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"6"}],"units":"Participants"}],"description":"Median (Range) for the maximum (peak) serum concentration by dose level stratified by study part and dose level.","dispersionType":"Full Range","groups":[{"description":"Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1. Beginning cycle 2, patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, temozolomide PO daily on days 1-5, and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 28 days for cycle 1 and 21 days for subsequent cycles for up to 17 cycles in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Part A Dose Level 1: 15 mg/m^2"},{"description":"Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1. Beginning cycle 2, patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, temozolomide PO daily on days 1-5, and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 28 days for cycle 1 and 21 days for subsequent cycles for up to 17 cycles in the absence of disease progression or unacceptable toxicity.","id":"OG001","title":"Part A Dose Level 2: 20 mg/m^2"},{"description":"Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1. Beginning cycle 2, patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, temozolomide PO daily on days 1-5, and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 28 days for cycle 1 and 21 days for subsequent cycles for up to 17 cycles in the absence of disease progression or unacceptable toxicity.","id":"OG002","title":"Part A Dose Level 3: 25 mg/m^2"},{"description":"Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1. Beginning cycle 2, patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, temozolomide PO daily on days 1-5, and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 28 days for cycle 1 and 21 days for subsequent cycles for up to 17 cycles in the absence of disease progression or unacceptable toxicity.","id":"OG003","title":"Part A Dose Level 4: 35 mg/m^2"},{"description":"Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1. Beginning cycle 2, patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, temozolomide PO daily on days 1-5, and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 28 days for cycle 1 and 21 days for subsequent cycles for up to 17 cycles in the absence of disease progression or unacceptable toxicity.","id":"OG004","title":"Part A PK Dose Level 4: 35 mg/m^2"}],"paramType":"MEDIAN","populationDescription":"All eligible patients with data collected","reportingStatus":"POSTED","timeFrame":"Up to 10 days","title":"C Max of Pevonedistat in Combination With Irinotecan and Temozolomide","type":"PRIMARY","unitOfMeasure":"ng/mL"}